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Pharmacokinetics in End Stage Renal Disease Patients

NCT04792333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-03-10

No results posted yet for this study

Summary

The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis.

Conditions

  • Healthy Volunteers
  • Renal Failure

Interventions

DRUG

firibastat

Single oral dose of 500 mg administration on Day 1

Sponsors & Collaborators

  • Eurofins Optimed

    collaborator INDUSTRY

  • Quantum Genomics SA

    lead INDUSTRY

Principal Investigators

  • Yves DONAZZOLO, MD · Eurofins Optimed

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2020-07-10
Completion
2020-07-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04792333 on ClinicalTrials.gov